Automated sequential injection and blood draw

ABSTRACT

Devices are provided to automatically inject drugs or other payloads into or beneath skin. These devices include an injector configured to drive a hollow needle into the skin and subsequently to deliver the payload through the hollow needle. Applied suction acts to draw blood from the puncture formed in the skin through the hollow needle, into the device, and to a sensor, blood storage element, or other payload. In some examples, the blood is drawn through the hollow needle when the hollow needle is penetrating the skin. In some examples, these devices are additionally configured to retract the hollow needle from the skin and/or to perform some other functions. These devices can be wearable and configured to automatically access blood or deliver a payload into skin, for example, to operate at one or more points in time while a wearer of a device is sleeping.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/635,580, filed Mar. 2, 2015, which is incorporated herein byreference.

BACKGROUND

Unless otherwise indicated herein, the materials described in thissection are not prior art to the claims in this application and are notadmitted to be prior art by inclusion in this section.

Certain medical states or conditions of a human body can be detected bydetecting one or more properties of blood in the body. In some examples,such medical states can be detected by extracting a sample of the bloodfrom the body and detecting the one or more properties of the extractedblood using a sensor or other system external to the body. For example,a lancet or other skin-penetrating device could be used to penetrate theskin such that blood is emitted from the skin and/or such that blood canbe caused to be emitted from the skin. In another example, a needle,tubing, and other equipment could be used to access blood in an arteryor vein of a body. Blood accessed from a body can be exposed to a sensor(e.g., a sensor placed in contact with blood at the surface of skin thathas been penetrated). Additionally or alternatively, accessed blood canbe stored for later analysis. In a particular example, a lancet can beused to penetrate skin, allowing blood to be emitted from the skin suchthat a blood glucose level of the blood can be measured using anelectrochemical sensor placed in contact with the emitted blood.

SUMMARY

Some embodiments of the present disclosure provide a system including:(i) a hollow needle having a first end that is configured to penetrateskin; (ii) a reservoir that contains a payload; (iii) an injectorconfigured to drive the hollow needle into the skin to form a puncturein the skin, to deliver the payload from the reservoir into the skin viathe hollow needle, and to retract the hollow needle from the skin; and(iv) a suction source configured to draw blood from the formed puncturein the skin into the system.

Some embodiments of the present disclosure provide a system including:(i) penetrating means containing a channel and having a first end thatis configured to penetrate skin; (ii) reservoir means that contain apayload; (iii) injector means configured to drive the penetrating meansinto the skin to form a puncture in the skin, to deliver the payloadfrom the reservoir means into the skin via the channel of thepenetrating means, and to retract the penetrating means from the skin;and (iv) suction means configured to provide suction to draw blood fromthe formed puncture in the skin into the system.

Some embodiments of the present disclosure provide a method including:(i) mounting a wearable device to skin, where the wearable deviceincludes: (a) a hollow needle having a first end that is configured topenetrate skin, (b) a reservoir, wherein the reservoir contains apayload, (c) an injector, and (d) a controller configured to operate theinjector; and (ii) operating the injector, using the controller, todrive the hollow needle into the skin to form a puncture in the skin andto deliver the payload into the skin through the channel.

Some embodiments of the present disclosure provide a wearable deviceincluding: (i) a hollow needle having a first end that is configured topenetrate skin; (ii) a reservoir that contains a payload; (iii) aninjector configured to drive the hollow needle into the skin to form apuncture in the skin and to deliver the payload from the reservoir intothe skin through the hollow needle; and (iv) a controller configured tooperate the injector to drive the hollow needle into the skin and todeliver the payload into the skin via the channel.

These as well as other aspects, advantages, and alternatives, willbecome apparent to those of ordinary skill in the art by reading thefollowing detailed description, with reference where appropriate to theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is an exploded view of an example device.

FIG. 1B is a cross-sectional view of the example device of FIG. 1A.

FIG. 2A is a cross-sectional view of an example device mounted to a skinsurface.

FIG. 2B is a cross-sectional view of the example device of FIG. 2A whena needle of the example device is piercing the skin.

FIG. 2C is a cross-sectional view of the example device of FIG. 2B whenthe fluid contained in the example device is being delivered into theskin.

FIG. 2D is a cross-sectional view of the example device of FIG. 2C whenthe needle of the example device has retracted from the skin.

FIG. 2E is a cross-sectional view of the example device of FIG. 2D whena sensor of the example device has been exposed to blood from the skin.

FIG. 3A is a cross-sectional view of an example device mounted to a skinsurface when a needle of the example device is piercing the skin.

FIG. 3B is a cross-sectional view of the example device of FIG. 3A whenthe fluid contained in the example device is being delivered into theskin.

FIG. 4A is a cross-sectional view of an example device mounted to a skinsurface when a needle of the example device is piercing the skin.

FIG. 4B is a cross-sectional view of the example device of FIG. 4A whenthe fluid contained in the example device is being delivered into theskin.

FIG. 5A is a cross-sectional view of an example device mounted to a skinsurface when a needle of the example device is piercing the skin.

FIG. 5B is a cross-sectional view of the example device of FIG. 5A whenthe fluid contained in the example device is being delivered into theskin.

FIG. 6A is a cross-sectional view of an example device mounted to a skinsurface when a needle of the example device is piercing the skin.

FIG. 6B is a cross-sectional view of the example device of FIG. 6A whenthe fluid contained in the example device is being delivered into theskin.

FIG. 7A is a cross-sectional view of an example device mounted to a skinsurface when a needle of the example device is piercing the skin.

FIG. 7B is a cross-sectional view of the example device of FIG. 7A whenthe fluid contained in the example device is being delivered into theskin.

FIG. 8A is a perspective top view of an example handheld body-mountabledevice.

FIG. 8B is a perspective bottom view of the example handheldbody-mountable device shown in FIG. 8A.

FIG. 9A is a perspective top view of an example wearable body-mountabledevice.

FIG. 9B is a perspective bottom view of the example wearablebody-mountable device shown in FIG. 9A.

FIG. 10 is a block diagram of an example system that includes aplurality of wearable devices in communication with a server.

FIG. 11 is a functional block diagram of an example device.

FIG. 12 is a flowchart of an example method.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying figures, which form a part hereof. In the figures, similarsymbols typically identify similar components, unless context dictatesotherwise. The illustrative embodiments described in the detaileddescription, figures, and claims are not meant to be limiting. Otherembodiments may be utilized, and other changes may be made, withoutdeparting from the scope of the subject matter presented herein. It willbe readily understood that the aspects of the present disclosure, asgenerally described herein, and illustrated in the figures, can bearranged, substituted, combined, separated, and designed in a widevariety of different configurations, all of which are explicitlycontemplated herein.

Further, while embodiments disclosed herein make reference to use on orin conjunction with a living human body, it is contemplated that thedisclosed methods, systems and devices may be used in any environmentwhere the operation of a device to inject a fluid or other materialsinto and/or to extract a fluid from an environment of interest bypiercing a barrier and/or penetrating an element within the environmentof interest is desired. The environment may be or include any living ornon-living body or a portion thereof, a gel, an emulsion, a fluidconduit, a fluid reservoir, an ampoule or other container containing adrug, an egg, etc.

I. Overview

A handheld, body-mountable, wearable, desktop, or otherwise-configureddevice may be configured to deliver fluids, drugs, inoculants, vaccines,nano- or micro-particles, microelectronics, or other materials orpayloads into a living body (or to insert some other payload into someother environment of interest). Such a device could include means forpenetrating or piercing the skin to allow the payload to be deliveredinto the skin. Such penetrating or piercing means could include one ormore hollow needles driven into the skin by an injector incorporatingchemical propellants, mechanical or electromechanical elements, or someother elements or components configured to drive the one or more hollowneedles into the skin and/or to deliver the payload into the skin viaone or more punctures or other penetrations in the skin formed by theone or more hollow needles.

Fluids, drugs, vaccines, nano- or micro-particles, microelectronics, orother payloads could be delivered, using embodiments described herein,for a variety of applications. Pharmaceuticals could be delivered totreat, manage, or otherwise affect a health state or condition of aperson. For example, the person could have diabetes and the deliveredfluid could include insulin or some other substance(s) configured tocontrol a blood sugar level of the person. Contrast agents or othersubstances (e.g., nano- or micro-particles) could be delivered tofacilitate imaging of structures of a person's body, to allow detectionof an analyte in the body (e.g., to detect cancer cells in the person'sbody), to collect an analyte in the person's body for elimination (e.g.,via the kidneys, via application of RF or other energies to the person'sbody) and/or extraction (e.g., using an embodiment herein configured toaccess and detect, collect, or otherwise interact with blood from aperson's body), or to facilitate some other application. In someexamples, payloads composed of solids, gels, emulsions, polymers, orother materials or objects could be delivered into a person's body inaddition to or alternative to fluids. For example, a sliver of adrug-eluting polymer, microelectronics including a biosensor, or someother payload could be delivered into skin using embodiments describedherein.

An injector or other means configured to drive one or more hollowneedles or other means for penetrating skin could be configured in avariety of ways to provide a force to drive the one or more hollowneedles into the skin and subsequently to deliver fluids (or some otherpayload) into the skin through the hollow needle(s). For example, theinjector could include a piston disposed in a chamber and to which theone or more needles are coupled; a propellant could be used to applypressure behind the piston to drive the piston, and attached one or moreneedles, forward such that the one or more needles are driven into theskin. A spring or some other means could also be provided to apply aforce to retract the one or more needles subsequent to being driven intothe skin. In a particular example, the propellant could include achemical or other material (e.g., nitrocellulose) that could be ignited(e.g., by being heated to an ignition temperature by, e.g., a resistiveheating element) to produce gases that could apply pressure on thepiston to drive the needle into skin. In another example, the propellantcould include compressed gases introduced into the chamber (e.g., byopening a valve, by puncturing a seal, by electrochemically generatingthe gases, by chemically generating the gases) and the compressed gasescould apply pressure on the piston to drive the needle into skin.Additionally or alternatively, an injector could include preloadedsprings, magnetic elements coupled to cams, motors, solenoids,ultrasonic vibrators, or other elements configured to drive one or moreneedles into skin.

The injector could additionally be configured to apply a force to areservoir containing the payload (e.g., a drug-containing fluid) orcould be configured in some other way to deliver the payload, throughthe hollow needle, into skin. For example, a spring, expandingpropellant gas, or some other force-generating means could applypressure on such a reservoir. Additionally or alternatively, a devicecould include a stop or some other means configured to arrest the motionof the hollow needle and/or reservoir as the hollow needle and/orreservoir move toward the skin to drive the hollow needle into the skin,and a driving mass or other means could apply a force to the reservoirrelated to the arrest of the hollow needle and/or reservoir such thatthe fluid is delivered, through the hollow needle, into skin. In someexamples, the injector could act to couple the channel of the hollowneedle with a fluid-containing reservoir (e.g., a reservoir containing apayload fluid under pressure) by opening a valve, moving the needleand/or reservoir relative to each other such that they are coupled,breaching a seal, or by some other coupling means. Other means (e.g.,application of suction, e.g., from a suction source of the device,chemical reactions, direction of fluids using hydrophobic/hydrophilicsurface coatings and/or wicking elements) to deliver fluids or otherpayloads into skin via a hollow needle are anticipated.

Such a payload-delivering device could additionally include suctionmeans for applying suction to draw blood into the device to be measured,detected, collected, stored, or otherwise used for some application(e.g., to draw blood into a collection chamber of the device). Forexample, such a blood-accessing device could include a sensor configuredto detect glucose in blood received by the device from the skin. Suchsuction could be applied to a seal and driving a needle into skin couldinclude driving the needle through the seal, exposing the skin to thesuction such that the suction draws blood from the skin, through theformed one or more holes in the seal, into the device (e.g., to asensor, blood collection element, or other component(s) of the device).Additionally or alternatively, suction could be applied through thehollow needle to draw blood into the device, through the hollow needle,when the needle is penetrating the skin. A body-mountableblood-accessing device could include multiple needles, injectors, seals,suction sources, sensors, blood storage elements, or other componentssuch that the body-mountable blood-accessing device could be operated toautomatically access blood from a wearer at a number of specified pointsin time, e.g., while the wearer sleeps.

In some examples, devices as described herein could receive, draw,and/or interact with blood emitted from the skin through some meansalternative or additional to one or more suction sources, e.g., byincluding hydrophobic and/or hydrophilic coatings, by including one ormore capillary tubes or other elements configured to wick the blood, orthrough some other means. Additionally or alternatively, a sensor, bloodstorage element, or other component(s) of the device could be locatedproximate to the puncture formed in the skin by the needle such thatblood emitted from the blood comes into contact with the sensor, bloodstorage element, or other component(s) of the device.

A suction source or other suction means configured to provide suction toskin, to a seal, and/or to some other elements to draw blood into adevice and/or to draw blood into a device by some other means (e.g.,through a hollow needle) could provide suction by a variety ofmechanisms. In some examples, the suction source could include a pump,an endobaric chemical process, a spring-loaded volume, or some otheractuated element(s) configured to be operated to reduce a pressure towhich the seal is exposed or to otherwise provide suction to the seal.In some examples, the suction source could include an evacuated volume,i.e., an enclosed volume having a lower pressure than the atmospheresurrounding the device such that, when the seal is breached, blood (orsome other fluid or material) is drawn through/toward the one or moreholes in the seal.

Such suction provided to skin could act to draw the skin toward thedevice (e.g., toward one or more holes formed in a seal of the device,e.g., by being pierced by a needle of the device). In some examples, thedevice could include a concave depression (e.g., a spherical domedepression) formed in a seal and/or in some other element(s) of thedevice such that the suction provided by the suction source could draw aportion of the skin into the concave depression. Such displacement ofthe skin could act to increase a rate and/or duration of the emission ofblood from the skin. A blood-accessing device could additionally oralternatively be configured in other ways to increase the rate and/orduration of the emission of blood from the skin following penetration byone or more needles. In some examples, heparin or some otheranti-clotting or anti-coagulating substance could be introduced on/inthe skin (e.g., by being deposited and/or injected by the one or morehollow needles). In some examples, an amount of blood flow in the skincould be increased by, e.g., applying suction to the skin (e.g., usingthe same or a different suction source as is used to drawn blood intothe device), applying a frictive force to the skin (e.g., by rubbing theskin), and/or heating the skin before driving the one or more hollowneedles into the skin.

Blood accessed by devices as described herein (e.g., by driving one ormore hollow needles into skin and receiving blood emitted from thepuncture formed in the skin by the hollow needles) could be used for avariety of applications. In some examples, the device could contain asensor that could be configured to detect one or more properties of theblood (e.g., to detect the concentration of an analyte in the blood).Sensors could be configured to detect glucose, blood cell counts,electrolytes, hormones, cholesterol, or some other analytes in accessedblood. Additionally or alternatively, devices as described herein couldbe configured to store accessed blood for later use, e.g., forinterrogation by sensors or other elements of some other devices orsystems. Storing blood could include providing heparin or otherstabilizing and/or anti-clotting agents such that the blood is stored asa fluid. Additionally or alternatively, accessed, stored blood could beallowed to dry, clot, coagulate, or engage in some other process, andthe dried or otherwise altered stored blood could be presented to asensor device configured to receive the stored blood. In some examples,one or more blood-storing elements of a blood-accessing device could beremovable, and could be removed from the device to be presented toanother system for analysis (e.g., the removable blood-storing aspectsof the device could be removed and sent to a centrally locatedlaboratory).

In some examples, a device may include a user interface that isconfigured to provide user-discernible indications (e.g., visual,audible, and/or tactile indications) of the operation of the device todeliver fluids or other payloads into skin and/or information aboutblood accessed by the device and sensed by sensors of the device,progress or other information related to a function of the device, orother information. In some examples, the user interface couldadditionally provide a means for one or more settings of the device(e.g., timing of one or more future activations of the device to deliverfluids or other payloads into skin, a user information privacy setting,a user's credentials to access a service) to be specified by a useraccording to the user's preferences. In some examples, the device mayinclude a wireless communication interface that can transmit/receivedata to/from an external device, for example, using Bluetooth, ZigBee,WiFi, and/or some other wireless communication protocol. The datatransmitted by the wireless communication interface may include dataindicative of one or more physiological parameters or health statemeasured and/or determined based on blood accessed by the device. Thewireless communications interface could additionally or alternatively beconfigured to receive data from an external system.

It should be understood that the above embodiments, and otherembodiments described herein, are provided for explanatory purposes, andare not intended to be limiting. Further, the terms ‘access,’‘accessed,’ ‘accessing,’ and any related terms used in relation to theoperation of a device to induce emission of blood from skin are usedherein (unless otherwise specified) to describe any operation orconfiguration of a device or system to receive blood from skin or fromsome other tissue. This could include receiving blood that has beenemitted from skin in response to cutting, piercing, incising, cutting,or otherwise penetrating the skin. This could include actively pulling,wicking, suctioning, or otherwise drawing such emitted blood from theskin and/or form the surface of the skin into the device and/or towardsome sensor, storage element, or other element(s) of the device. Theterm “payload” and any related terms used in relation to the operationof a device to deliver a fluid, gel, solid, manufactured object, orother material or materials into or through skin are used herein (unlessotherwise specified) to describe any fluids, gels, hydrogels, emulsions,drugs, vaccines, inoculants, micro- or nano-particles, microelectronics,polymers, or other materials or combinations of materials that could bedelivered, though a hollow needle, into or through skin or into orthrough some other environment of interest.

Embodiments as described herein could provide all or any subset of thefunctionalities described herein. For example, a device could beconfigured to penetrate skin with a hollow needle and to deliver a fluidor other payload into the skin through the hollow needle. In anotherexample, such a device could additionally be configured to retract thehollow needle from the skin subsequent to delivering the payload intothe skin. In yet another example, a device could be configured topenetrate skin with a hollow needle, to deliver a fluid or other payloadinto the skin through the hollow needle, and to detect one or moreproperties of and/or to collect blood emitted from the skin in responseto being pierced by the hollow needle.

Further, while examples and embodiments described herein refer todelivering fluid or other payloads into skin and/or accessing blood fromskin, it should be understood that methods, devices, and otherembodiments described herein could be employed to deliver payloads toand/or access other fluids from other environments of interest.

II. Example Operation of Devices to Deliver Substances Into Skin

A device could be configured in a variety of ways to deliver a fluid,material, manufactured device or object, or some other payload into skinor into some other tissue or environment. Such a device could include avariety of penetrating means (e.g., one or more hollow needles)configured to be driven into the skin by injecting means (e.g., by apiston and a chemical propellant) such that fluids or other payloads canbe delivered by delivery means, through the hollow needle, from areservoir or other storage volume/element(s) into the skin. In someexamples, the delivery means could be part of the injecting means, e.g.,an expanding propellant gas could act to drive the hollow needle intothe skin and to apply a force on a reservoir to deliver fluid or someother payload through the hollow needle into the skin. The device couldadditionally include means (e.g., part of the injecting means) tosubsequently retract the hollow needle from the skin (e.g., by forceapplied by a spring). In some examples, blood can be emitted from theresultant wound (e.g., puncture) in the skin, and the emitted bloodcould be drawn into, collected by, or otherwise interacted with by thedevice for a variety of applications. Toward such ends, devices couldinclude a variety of means (e.g., suction sources, seals, channels,concave depressions) configured to draw blood out of the skin (e.g.,through the hollow needle, through a hole in a seal of the device), todraw blood emitted from the skin into the device, and/or to direct suchaccessed blood toward one or more sensors, blood storage elements, orother elements of the device. Further such devices could includeadditional elements, sensors, controllers, user interfaces, powersources, communications interfaces or other elements according to anapplication.

Such devices could be configured to be used to penetrate, pierce,deliver payloads into, access, detect, store, or otherwise interact withblood from, or otherwise interact with skin or other elements of a bodyin a variety of ways. In some examples, such devices could be configuredto be mounted to skin or otherwise worn such that the device can injectpayloads into skin and/or access blood automatically, e.g., a controlleror other element(s) of the device could operate an injector of thedevice to pierce the skin and deliver payloads and/or access blood whilea wearer of the device sleeps. Alternatively, the device could be ahandheld device configured to be manually mounted to a portion of skinand operated to deliver a payload and/or access blood from the skin. Insome examples, the device could be wall-mounted, situated on a desktop,or disposed or mounted in some other way, and mounting the device toskin could include positioning an arm or other aspect of a bodyproximate to the device (e.g., positioning skin of the wrist of a personproximate to a specified aspect of the device). In some examples, one ormore elements (e.g., injectors, needles, reservoirs, seals, suctionsources, sensors, blood storage elements) could be removable from thedevice, e.g., such that other elements of the device (e.g., controllers,user interfaces, mounts) could be reusable by replacing used removableelements of the device.

The payload could include a variety of fluids, liquids, gels, emulsions,hydrogels, solid elements, particles, compounds, microelectronicelements, compounds, drugs, pharmaceuticals, vaccines, cells, and/orother materials or combinations of materials. In some examples, one ormore aspects of the payload (e.g., microparticles, nanoparticles, rigidcomponents, microelectronic components, cells, micelles) could bedisposed in a carrier fluid of the payload. The carrier fluid of thepayload could be configured to reduce a friction of other elements ofthe payload as the other elements are delivered from the device, throughthe hollow needle and into the skin. The carrier fluid could beconfigured to transmit a force or pressure exerted on a reservoir to theother elements of the payload to facilitate delivery of the otherelements into the skin. The carrier fluid could include drugs (e.g.,heparin) or other substances (e.g., an adhesive to maintain anelectronic biosensor of the payload in the skin once delivered) or couldbe configured in some other way to provide other functions. In someexamples, a viscosity, density, degree of shear thickening, or otherproperties of the payload could be controlled by adding substances to afluid of the payload. For example, a gelling agent could be added to afluid of the payload. Gelling agents could include hydrogel-formingpolymers or monomers, superabsorbent materials, gelatin, proteins, orother materials that, when added to the fluid of the payload, increase aviscosity or density of the fluid of the payload.

Fluids, drugs, vaccines, inoculants, devices, electronics, objects, orother payloads delivered into skin using devices and methods disclosedherein could be configured in a variety of ways and used for a varietyof applications. The volume of a fluid (or other material) delivered canbe related to the configuration of the device. The device could beconfigured (e.g., a stroke length, a force applied to a reservoir and/ora compliance of materials composing the reservoir, a viscosity of afluid payload and/or carrier fluid of the payload contained in thereservoir, a diameter of the channel in one or more hollow needles) todeliver a specified minimum amount of the payload according to anapplication of the device. For example, the device could be configuredto deliver a sufficient amount of a drug-containing fluid payload toeffect a specified change in the function of a person's body (e.g., tocontrol a blood sugar level of the person's body). In another example,the device could be configured to deliver fluids or other payloads(e.g., a microelectronic biosensor or some other electronic device) to aspecified location or layer within or beneath the skin, e.g., a lengthof a hollow needle and/or a stroke length of the motion of the hollowneedle into the skin when driven by an injector could be specified todeliver a payload to the subcutaneous layer beneath skin.

Blood accessed using devices and methods disclosed herein could be usedfor a variety of applications. Such applications could include anyapplications where one or more properties of a person and/or of blood ofthe person can be detected or determined from a volume of blood accessedusing such devices. The volume of blood can be related to theconfiguration of the device, and could be between approximately one andapproximately 10 microliters. For example, the device could beconfigured to access (e.g., to penetrate the skin and to apply suctionto the skin to draw) more than approximately 3 microliters of blood andto detect the concentration of one or more analytes (e.g., glucose,hormones, blood cells) in the accessed blood. The device could beconfigured (e.g., a stroke length, diameter or shape of a needle, theshape of a concave depression into which skin could be drawn by suction,an amount of applied suction) to provide a specified minimum amount ofblood according to a property of the blood to be measured and/or asensor used to detect such a property. For example, the device could beconfigured to access sufficient blood to allow detection of a glucoselevel of the blood using an electrochemical sensor disposed in thedevice. In another example, the device could be configured to access andstore a sufficient amount of blood to allow detection of a property ofthe blood by some other device or system that is provided with thestored blood from the blood-accessing device.

An example of such a payload-delivering and blood-accessing device isillustrated in FIGS. 1A and 1B. FIG. 1A shows an expanded perspectiveview of components of the device. FIG. 1B is a cross-sectional view ofthe device 100 illustrating in detail elements of the device 100. Thedevice 100 includes a housing 110 that is formed to include a chamber131 and an evacuated volume 141 as well as other features. The device100 could be used on its own (e.g., by placing a bottom surface of thedevice 100 in contact with skin), could be part of another device (e.g.,part of a wrist-mountable or otherwise body-mountable device), could bea removable module of another device, or could be configured or operatedin some other way.

The device 100 includes a number of elements disposed within the chamber131 formed in the housing 110. The chamber 131 is shown as a cylindricalshape formed in the housing, but could assume other shapes according toan application. The chamber contains a hollow needle 120 (i.e., a needleformed to have a contained needle channel 125 along its length)configured to penetrate skin. A piston 130 is coupled to the needle 120and configured to slidably move within the chamber 131 (e.g., along thelong axis of the chamber 131). A reservoir 150 containing a payload 155(for example, a drug-containing fluid, gel, or hydrogel) is formed inthe piston 130 and coupled to the needle channel 125 within the hollowneedle 120. The chamber 131 additionally contains a propellant 135configured (a) to slidably move the piston 130 within the chamber 131 todrive the needle 120 into skin, (b) to drive the needle 120 through aseal 143 disposed on a bottom surface of the housing 110, and (c) toapply a force to reduce a volume of the reservoir (e.g., by collapsingand/or displacing one or more elements of the reservoir) such that thepayload 155 is delivered from the reservoir 150 through the needlechannel 125 and into skin that is penetrated by the hollow needle 120.

The chamber additionally contains a spring 137 configured to retract theneedle 120 from the skin, a sealant layer 139 that is configured to bepierced by the hollow needle 120 and a resistive element 136 configuredto ignite the propellant 135 by providing sufficient heat to thepropellant 135 when current passes through the resistive element 136.The top of the chamber 131 is closed by a circuit board 115 or othermember bonded or otherwise adhered to the housing 110. Electronics 150(e.g., one or more controllers, logic gates, current sources, electronicswitches, radio transceivers, analog-to-digital converters) disposed onthe circuit board 115 could be configured to perform operations of thedevice 100, e.g., to apply current to the resistive element 136 (or toother resistive elements or to operate other components of otherinjectors of the device 100) to ignite the propellant 135 at a specifiedpoint in time, to operate a sensor to detect a property of bloodaccessed from skin by the device 100, or to perform some otheroperations according to an application.

A hole is formed in the bottom of the chamber 131 through the housing110 such that the hollow needle 120 can be driven into skin proximatethe bottom of the housing 110. A chamber vent 132 is formed in thehousing 110 to allow gases produced by the ignition of the propellant135 to be vented out of the device such that the spring 137 can retractthe hollow needle 120 subsequent to the ignited propellant 163 causingthe piston 130 to drive the hollow needle 120 through the seal 143 andinto skin. The diameter, number, geometry, and other properties of thevent 132 and or additional vents formed in components of the device 100(e.g., through the piston, through the wall of the chamber 131 atadditional or alternative locations) could be specified to control aforce with which the piston 130 drives the hollow needle 120, a durationof time during which the hollow needle 120 penetrates skin before beingretracted by the spring 137, or other properties of operation of thedevice 100.

The seal 143 includes a concave depression 123 through which the hollowneedle 120 penetrates the seal 143 to form a hole in the seal 143 whendriven downward by the piston 130. A channel 145 is formed above theconcave depression 123 behind the seal 143 and connecting the regionbehind the seal 143 with an evacuated volume 141 formed in the housing110. The top of the evacuated volume 141 is sealed by the circuit board115. Atmospheric gases are prevented from entering the evacuated volume143 through the chamber 131 by the sealant layer 139 and prevented fromentering the evacuated volume 141 through the bottom of the housing 110(e.g., through the concave depression 123) by the seal 143. A sensor 140is contained within the channel 145 proximate the concave depression123. The pressure in the evacuated volume 141 is sufficiently lower thanthe pressure of the environment surrounding the device 100 that, whenone or more holes are formed in the seal 143 by the hollow needle 120,the evacuated volume 141 acts as a suction source to draw blood fromskin, through the one or more holes in the seal 143, and into contactwith the sensor 140 such that the sensor 140 can detect one or moreproperties of the blood (e.g., a glucose concentration of the blood). Insuch an example, the evacuated volume 141 could additionally act as acollection chamber for blood. The evacuated volume 141 could have apressure less than approximately 50 kilopascals. Other elements of thedevice 100 (e.g., the channel 145, the concave depression 123, the holeformed in the bottom of the chamber 131, the needle channel 125, or someother elements of the device 100 could act as a collection chamber forblood drawn from skin by a suction source and/or received by the device100 by some other means.

The device 100 could additionally include a conformal layer configuredto conform to the skin such that suction applied by the evacuated volume141 (or by some other suction source of the device 100) through one ormore holes in the seal 143 (or by some other means, e.g., through theneedle channel 125) is applied to skin proximate the one or more holesin the seal 143. Such a conformal layer could include polyurethane, softrubber, polymeric gel, or some other compliant material. Additionally oralternatively, such a conformal layer could include a glue (e.g.,cyanoacrylate), a tape, a dry adhesive, or some other adhesivesubstance.

The shape, size, geometry, or other properties of the concave depression123 could be specified to maximize an amount of blood emitted from skinin response to being pierced by the hollow needle 120. For example, theconcave depression 123 could have a conical shape. The device 100 couldadditionally or alternatively be configured in other ways to maximize anamount of blood emitted from skin. For example, the device 100 could beconfigured to increase blood flow in the skin proximate the device 100and/or proximate the concave depression 123 by, e.g., heating the skinbefore penetration, applying a frictive force to the skin beforepenetration (e.g., by rubbing the skin), applying suction to the skinbefore penetration, applying a vasodilating, anti-clotting,anti-coagulant, or other pharmaceutical (e.g., heparin, lidocaine)before, during, and/or after penetration of the skin, or by beingconfigured or operated in some other way. Pharmaceuticals could bedelivered as a coating on the needle 120. Additionally or alternatively,the needle 120 could be used to deliver a pharmaceutical or othersubstance and/or to suction blood into the device 100 via the needlechannel 125.

Further, the properties of the needle 120 could be specified to maximizethe amount of blood emitted from skin, maximize an amount of fluid orsome other payload delivered into skin, control a depth and/or layerinto which a payload is delivered into the skin, to minimize discomfortinduced by penetration of the skin, or according to some otherconsideration. For example, the tip of the needle 120 could include atriple-bevel to minimize deflection of the skin 105 and/or to minimizeinduced discomfort due to piercing of the skin by the hollow needle 120.Alternatively, the needle 120 could have a chisel tip (e.g., a singlebevel), could have a flat ‘razor’ blade end, could include a taper(e.g., could become thinner toward the end), could be round, flat, orcould be configured in some other way to, e.g., maximize blood emittedfrom skin. The hollow needle 120 could be serrated. The diameter (orgauge) of the hollow needle 120 could be specified to maximize theamount of blood emitted from skin and/or to minimize discomfort inducedby piercing of skin by the hollow needle 120. For example, the hollowneedle 120 could have a gauge between approximately 21 gauge andapproximately 36 gauge.

In some examples, the payload could be a fluid that includes gellingagents, and the amount, type, or other properties of the gelling agentscould be specified to control an amount of the payload that is deliveredinto skin, a timing of delivery of the payload into the skin, or someother property of the operation of the device (e.g., by controlling aviscosity, a degree of shear thickening, an osmolarity, or some otherproperties of a fluid payload).

In some examples, the piston 130 could drive multiple hollow and/orsolid needles into the skin. A spacing between such multiple needles, anumber of the needles, the lengths and diameters of the needles, thegeometry of the tips of the needles, the presence of a channel withinthe needles and a diameter and other properties of such a channel, orother properties of the needles could be specified to maximize theamount of blood emitted from skin pierced by the needles, to control anamount and or depth or layer to which one or more fluids or otherpayloads are delivered into skin by the needles, and/or to minimizediscomfort induced by piercing of skin by the needles. For example, thespacing between the needles could be specified to maximize thelikelihood of piercing at least one blood vessel in the skin when thepiston 120 drives the needles into the skin.

Further, the distance the hollow needle 120 (or needles) pierces intoskin (related, e.g., to properties of the propellant 135, chamber 131,piston 130, spring 137, hollow needle 120, and/or other elements of thedevice 100) could be specified to maximize the amount of blood emittedfrom the skin, a depth and/or layer into which the payload 155 isdelivered, and/or to minimize discomfort induced by piercing of the skinby the hollow needle 120. For example, the device 100 could beconfigured such that the hollow needle 120 penetrates skin to a depth ofapproximately 2 millimeters. In some examples, the device 100 could beconfigured such that the hollow needle 120 penetrates skin to a depththat contains capillaries and/or other blood vessels but that does notcontain many nerve endings (e.g., to a depth near the transition betweenthe epidermis and dermis layers of the skin). Additionally oralternatively, the device 100 could be configured to drive the hollowneedle 120 into the skin at a different angle than the one depicted(i.e., an angle other than approximately 90 degrees).

The propellant 135 could include a variety of chemicals and combinationsof chemicals. For example, the propellant 135 could includenitrocellulose, butane, azide, or some other energetic gas-producingsubstance or other chemical(s). In some examples, the propellant couldbe formed and/or modified before use, e.g., the propellant could includeoxygen and hydrogen formed from water by electrolysis. Alternatively,the propellant could include a compressed gas (e.g., CO2, N2, aircompressed by a pump or other means, a gas generated by the device 100by electrolysis or some other method or means) to which the piston 130is exposed to drive the hollow needle 120 into the skin 105 and/or todeliver the payload 155 into skin though the needle channel 125.Additionally or alternatively, the piston 130 could be driven by a lowpressure (e.g., a vacuum, a suction source, an evacuated volume) beneaththe piston 130.

The use of the resistive element 136 to ignite the propellant 135 isintended as a non-limiting example. Other means for igniting a chemicalpropellant (or some other chemical or element of the device 100according to an application) are anticipated, including but not limitedto generating an electrical spark (e.g., by applying a high voltageacross a spark gap or between electrodes of the device 100),illuminating the propellant (e.g., using a laser, an LED, or some otherlight-emitting element(s)), applying a force and/or vibration to thepropellant (e.g., using a piezoelectric elements), or changing apressure to which the propellant is exposed. Further, the illustratedconfiguration of the chamber 132 vent is a non-limiting example; more orfewer vents, vents located at different locations, or vents configuredin some other way (e.g., through the piston 130) could be included tofacilitate a piston driving a needle into skin and/or subsequentlyretracting the needle from the skin. In an example, one or more of thevents could be normally closed and configured to open (eitherpermanently or temporarily) when a pressure across the vent exceeds somelevel (e.g., when the pressure behind the piston 130 increases above aspecified pressure due to ignition of the propellant 135). Additionallyor alternatively, one or more vents could be located in the chamber 131such that gases behind the piston 130 (e.g., high-pressure gasesproduced by ignition of the propellant 135) are able to leave thechamber 131 through the vent only when the piston 130 is displaceddownward in the chamber 131 by some specified distance.

The piston 130, chamber 131, propellant 135, spring 137, and otherelements of the device 100 comprise an injector configured to drive thehollow needle 120 into skin, to deliver the payload 155 from thereservoir 150 into skin through the hollow needle 120, and subsequentlyto retract the needle from the skin by igniting a chemical propellant.However, the device 100 could include additional or alternativeinjectors configured to achieve driving of the hollow needle 120 intoskin, delivery of payloads, and subsequent retraction of the hollowneedle 120. In some examples, the injector could include one or morepre-loaded springs configured to be released (e.g., by a manual button,by a solenoid or other electromechanical actuator). The injector couldinclude one or more magnets and/or cams configured to translate a forcebetween the one or more magnets and other elements of the device 100 toproduce driving and/or retracting force(s) that could be applied to thehollow needle 120 and/or elements of the reservoir 150. In someexamples, the injector could include one or more motors or otherelectromechanical actuator configured to apply driving and/or retractingforce(s) directly to the hollow needle 120 and/or reservoir 150 (e.g.,through a rack-and-pinion mechanism, using a cam, by applying magneticforces using a solenoid) and/or by charging up a spring (e.g., a rotaryspring) that could apply such force(s). In some examples, the hollowneedle 120 could be applied against the skin with a constant force thatis less than a force necessary to pierce the skin, and a vibrator (e.g.,a vibrating motor, a piezoelectric or otherwise configured ultrasonictransducer) could vibrate the hollow needle 120 such that the hollowneedle 120 pierces the skin. Other injectors or other means and methodsfor driving the hollow needle 120 into the skin, delivering the payload150 through the needle channel 125 into the skin, and subsequentlyretracting the needle are anticipated.

Suction applied to the seal 143 and/or to some other element(s) of thedevice 100 could be applied by a variety of means or methods. Asillustrated in FIGS. 1A and B, suction can be provided by an evacuatedvolume 141 that has a pressure that is lower than the pressure of theatmosphere surrounding the device 100. Additionally or alternatively,suction could be provided by a pump, a chemical process that causes adecrease in pressure (e.g., by causing a decrease in temperature, byconsuming nitrogen, oxygen, or some other gas from an enclosed volume(e.g., 141) and/or by changing a phase of such gases), a spring-loadedor otherwise actuated, enclosed volume that can be actuated to increasein size (thus producing suction), or by some other means of producingsuction. In some examples, blood emitted from skin (e.g., due topenetration of the skin with a needle as described herein) could bedrawn into the device 100, applied to a sensor (e.g., 140), stored, orotherwise manipulated according to an application without using a sourceof suction, e.g., by using hydrophobic and/or hydrophilic coatingsand/or capillary forces to control the location and/or movement of bloodwithin and/or relative to the device 100, by locating a sensor, bloodstorage element, or other element(s) of the device 100 proximate to thelocation at which the device 100 pierces the skin with the hollow needle120, or by configuring the device 100 in some other way. In someexamples, e.g., when the hollow needle 120 pierces a vein or otherlarger vasculature, blood pressure or other forces within or beneathskin may cause a sufficient amount of blood to be emitted from the skin.

When suction is provided by a suction source that comprises an evacuatedvolume (e.g., 141), a pressure within the evacuated volume could bespecified to provide sufficient suction, for example, the pressurewithin the evacuated volume could be less than approximately 50kilopascals. Further, the device 100 could be constructed such that theevacuated volume has a pressure less than some maximum value (e.g., 50kilopascals) for some specified minimum period of time such that theevacuated volume could be used as a suction source to draw blood intothe device 100 at a specified future point in time. This could includethe device 100 including high-quality seals and adhesives betweenelements of the device 100 that comprise and/or form the evacuatedvolume. In some examples, surfaces of elements (e.g., the housing 110,the seal 143, the circuit board 115) of the device 100 that are joinedto form the evacuated volume could have highly smooth surfaces. In someexamples, the device 100 could be configured and/or assembled such thatthe pressure within the evacuated volume remains below a specifiedmaximum pressure for 48 hours, a week, or some other specified period oftime to permit the use of the evacuated volume to provide suction todraw blood into the device 100 at a specified future point in time thatis less than the specified period of time. In some examples, this couldinclude storing the device 100 in an evacuated volume of a package(e.g., within an evacuated and sealed blister of packaging material) andremoving the device 100 from the evacuated volume of the package beforemounting the device 100 to skin.

The seal 143 could be composed of a variety of materials to allowsuction to be applied to and contained by the seal 143 until the seal ispierced by the hollow needle 120. Further, the seal 143 could becomposed of materials that are capable of being vacuum-formed into aspecified shape (e.g., a shape that can be mounted to the housing 110and that includes one or more concave depressions, e.g., 123). Forexample, the seal 143 could be composed of polycarbonate.

The sensor 140 could be configured to detect a variety of properties ofblood drawn into the device 100. For example, the sensor 140 could beconfigured to detect the presence, concentration, or other properties ofan analyte (e.g., glucose, small molecules, cells, cell counts,hormones, cholesterol, testosterone, thyroid hormones, vitamins,minerals, electrolytes, cortisol, creatinine, luteinizing hormone,follicle stimulating hormone) in the blood. In some examples, the sensor140 could be configured to detect a clotting rate, viscosity,osmolarity, or other property of the blood. The sensor 140 could beconfigured to detect the property of the blood through direct contactbetween the blood and one or more elements of the sensor 140. Forexample, the sensor 140 could be an electrochemical sensor configured toamperometrically, potentiometrically, or otherwise electrochemicallydetect one or more properties of the blood when the blood comes intocontact with one or more electrodes of the electrochemical sensor (e.g.,when the blood comes into contact with a working electrode of the sensor140 that is selectively sensitive to an analyte of interest in the bloodand further comes into contact with a reference electrode of the sensor140). In another example, the sensor 140 could be configured to detect aproperty of the blood when the blood comes into contact with ananalyte-sensitive chemical (e.g., a fluorophore, a chromophore) that hasone or more optical properties (e.g., a color, a fluorescence intensity,a fluorescence lifetime) that are related to the analyte in the blood,and the sensor 140 could detect the analyte in the blood by opticallyinterrogating (e.g., illuminating and/or detecting light emitted from)the analyte-sensitive chemical. Additionally or alternatively, thesensor 140 could be configured to detect one or more properties of theblood without being in direct contact with the blood, e.g., by detectinga color of the blood, a property of motion of the blood, or some otherproperty.

In some examples, the sensor 140 (or some other components of thedevice) could be configured to interact with micro- or nano-particlesdelivered into the skin and/or to interact with electronics (e.g., amicroelectronic biosensor) delivered into the skin by thepayload-delivering device 100. For example, the payload 155 couldinclude a plurality of microparticles and/or nanoparticles configured tohave a property that can be interrogated and/or detected by the sensor140 and that is related to one or more properties of the skin. Forexample, the payload could comprise a plurality of particles that aresensitive to an analyte in the skin and/or in the body (e.g., a protein,a cancer cell). Further, the particles could have an optical,electrical, magnetic, electromagnetic, or other property that is relatedto a property of the analyte (e.g., a concentration of the analyte, astate of the analyte, binding of the analyte to one or more of theparticles) such that the particles emit electromagnetic energy relatedto (e.g., having an amplitude, frequency, polarization, phase, timing,wavelength or other property related to) the property of the analyte inresponse to receiving interrogating electromagnetic energy (e.g., inresponse to the sensor 140 or some other device emitting radio frequencyenergy toward the particles in the skin). In some examples, theparticles emitting electromagnetic energy could include the particlesreflecting, absorbing, fluorescently or otherwise absorbing andre-emitting, or otherwise interacting with the interrogatingelectromagnetic energy. Additionally or alternatively, some system otherthan the sensor 140 and/or device 100 could be configured and operatedto detect one or more properties of the skin by interacting with suchmicroparticles and/or nanoparticles delivered into the skin by thedevice 100.

In another example, the payload could include one or more electronicdevices configured to perform some function within and/or beneath theskin. For example, the payload could be an electronic biosensor thatincludes one or more sensors configured to detect a property of skinand/or of some other tissue to which the sensor(s) is exposed (e.g., todetect a concentration of an analyte, to detect an electrical field, todetect a temperature, to detect a pH). The electronic biosensor couldfurther include microfabricated electronics configured to operate thesensor(s), to receive energy wirelessly to power the electronicbiosensor (e.g., to receive RF energy emitted by the sensor 140 and/orby some other component(s) of the device 100), to receive energyelectrochemically from the skin to power the electronic biosensor, torecord information about the skin detected using the sensor(s), totransmit information about the skin detected using the sensor(s) to thesensor 140 and/or to some other component(s) of the device 100 (e.g., byreflecting electromagnetic energy emitted toward the electronicbiosensor as backscatter radiation), or to perform some other operationsof an the electronic biosensor according to an application. Additionallyor alternatively, some system other than the sensor 140 and/or device100 could be configured and operated to operate the electronic biosensor(e.g., by emitting electromagnetic radiation toward and/or receivingelectromagnetic radiation from the electronic biosensor).A device asdescribed herein could be configured to store blood emitted and/or drawnfrom skin (e.g., for some later analysis). Such a blood storage elementcould include a capillary tube, an ampoule, a basin, a pit, or someother geometry configured to contain blood. Further, a blood storageelement could be configured to preserve, chemically modify, preventclotting or coagulation of, or otherwise manipulate the stored blood.For example, the blood storage element could contain heparin to preventclotting and/or coagulation of drawn, stored blood. Alternatively, theblood storage element could be configured to allow the blood to dry,according to an application. In some examples, the blood storage elementcould include an absorptive material, e.g., a piece of fabric configuredto absorb blood or other fluids.

Stored blood could be presented to a sensor or other element(s) of asensing device (e.g., a desktop or other device separate from ablood-accessing device as described herein, e.g., 100) configured todetect one or more properties of the stored blood. For example, a bloodaccessing device could be configured to be mounted to such a sensingdevice and to provide the stored blood to the sensing device. This couldinclude the sensing device detecting one or more properties of thestored blood while it remains in the blood-accessing device (e.g., byoptically detecting a property of the stored blood by illuminatingand/or receiving light from the stored blood through a window, anoptical fiber, or other optically transparent elements of theblood-accessing device). Additionally or alternatively, theblood-accessing device providing the stored blood to a sensing devicecould include the stored blood being removed from a blood storageelement or other components of the blood-accessing device.

A payload-delivering and/or blood-accessing device or system asdescribed herein (e.g., 100) could include multiple sensors,blood-storage elements, needles, injectors, seals, and/or otherelements. For example, a device could include multiple sections thateach include a respective hollow needle, injector, reservoir, suctionsource, and/or other elements. Each section could be configured to driveits respective hollow needle into skin, to subsequently deliver apayload from a respective reservoir into the skin through the needle, toretract the needle from the skin, and to receive blood emitted from theskin in response to being penetrated by the needle. Each section couldinclude one or more sensors, one or more blood storage elements, and/oradditional components configured to receive, transmit, measure, modify,or otherwise interact with blood received from the skin. The sections ofa device could be similarly configured (e.g., could include similarsensors, be configured to draw similar amounts of blood from skin in asimilar manner, be configured to deliver a similar fluid, drug, or otherpayload) or could be differently configured (e.g., different sensors,differently configured injectors, differently configured needles,different delivered fluids/drugs/payloads). The sections of a devicecould be operated to access blood from skin and/or deliver a payloadinto skin at respective different points in time, e.g., at a number ofpoints in time while a wearer of the device is asleep, at a number ofpoints in time during a week, in response to a command received from auser and/or from a remote system in communication (e.g., wirelesscommunication via Bluetooth, ZigBee, WiFi, or some other wirelesscommunications protocol), in response to a detected command (e.g., abutton press) and/or behavior (e.g., performance of an exerting athleticactivity, detected using, e.g., an accelerometer of the device 100) of awearer, based on a detected physiological state of the wearer (e.g., aheart rate or blood pressure detected by sensor(s) of the device 100),or according to some other scheme.

Further, a device could include more or fewer sections, organizedsimilarly or differently (e.g., in a row, rather than circularly asillustrated) than those embodiments illustrated herein. For example, ablood-accessing device could include a single section (e.g., device100). In examples wherein the injector and/or suction source aresingle-use (e.g., wherein the injector ignites a limited supply of apropellant and/or wherein suction is provided by a single evacuatedvolume) and the device includes a single such section, theblood-accessing and/or payload-delivering device could be configured fora single use. In some examples, such a single and/or limited-use (e.g.,a single use, as illustrated in FIG. 1A) device could be configured tobe a removable and/or replaceable element of some other device. Forexample, the blood-accessing and payload-delivering device 100 could beconfigured to be removably mounted on or within a body-mountable device(e.g., a wrist-mountable device) that includes a controller, a userinterface, a battery, a communications interface, or some otherelements. Such a body-mountable device could be configured to operatethe limited-use device to access a number of samples of blood from skinand/or to deliver a number of amounts of a fluid or other non-discretepayload into skin (e.g., at respective specified points in time). Oncethe body-mountable device has operated all of the limited-use sectionsof the device, the device could be removed from the body-mountabledevice and replaced. In some examples, the removed device could beconfigured to store blood, and blood stored in the removedblood-accessing device could be presented to a sensing device foranalysis (e.g., the removed device could be sent via post to a sensingdevice at a laboratory that is remote from a user of the body-mountabledevice).

FIGS. 2A-D illustrate the operation of a device 200 to deliver a payloadinto skin 205 and to access blood from the skin 205. The device 200includes a housing 210 into which is formed a chamber 231. The chambercontains a hollow needle 220 configured to penetrate the skin 205. Apiston 230 is coupled to the needle 220 and configured to slidably movewithin the chamber 231. A reservoir 250 containing a payload 255 isformed in the piston 230 and coupled to a channel of the hollow needle220. The chamber 231 additionally contains a propellant 235 configuredto slidably move the piston 230 within the chamber 231 to drive thehollow needle 220 into skin 205 and to apply a force to reduce a volumeof the reservoir 250 such that the payload 255 is delivered from thereservoir 250 through the hollow needle 220 and into the skin 205. Thechamber additionally contains a spring 237 configured to retract thehollow needle 220 from the skin and a resistive element 236 configuredto ignite the propellant 235.

A hole is formed in the bottom of the chamber 231 through the housing210 such that the hollow needle 220 can be driven into skin 205proximate the bottom of the housing 210. A chamber vent 232 is formed inthe housing 210 to allow gases produced by the ignition of thepropellant 235 to be vented out of the device such that the spring 237can retract the hollow needle 220 subsequent to the ignited propellant235 causing the piston 230 to drive the hollow needle 220 into the skin205. A sensor 140 is located proximate the location on the skin 205 thatcould be pierced by the hollow needle 120.

FIG. 2A shows the device 200 having been mounted to the skin 205; thiscould include the device 200 being a handheld device designed to bemanually or otherwise maintained in contact with the skin 205.Alternatively, the device 200 could be adhered to the skin 205 using anadhesive or mount (e.g., a mount configured to encircle a wrist of aperson such that the device 200 is maintained in contact with skin ofthe wrist). In another example, the device 200 could be a desktop orother relatively immobile device and a body part comprising the skin 205could be positioned proximate the device 200 as illustrated.

FIG. 2B shows the propellant 235 expanding to slidably move the piston230 downward, compressing the spring 237 and driving the hollow needle220 into the skin 205. Properties of the spring 237 (e.g., a springconstant, a degree of initial loading), piston 230 (e.g., a mass, acoefficient of friction with the sides of the chamber 231, a diameterand number of piston vents 232), hollow needle 220 (e.g., a diameter, atip geometry, the presence of a fluoropolymer coating or otheranti-friction coating), chamber 231 (e.g., a geometry, a volume of theregion above the piston), propellant 235 (e.g., an amount of thepropellant, a mix of chemicals comprising the propellant), or otherelements of the device 200 could be specified to maximize the speed withwhich the needle 220 is driven into the skin 205 to, e.g., reducediscomfort induced in a user by operation of the device 200 to penetratethe skin 205.

FIG. 2C shows the propellant 235 further expanding to apply a force toreduce a volume of the reservoir 250 such that the payload 255 isdelivered into the skin 205 through the hollow needle 220 (as deliveredpayload 257; note that the payload, in this example, is a fluid, butthat other payloads, including gels, polymers, solid materials,polymers, micro- and nano-particles, microelectronic components, orother materials or combinations of materials are anticipated).Properties of the reservoir 250 (e.g., a spring constant and/orcompliance of an elastic membrane of the reservoir 250 separating thepayload 255 from the expanding propellant 235, a shear strength of acollapsible or partially collapsible element of the reservoir 250),hollow needle 220 (e.g., a diameter, a tip geometry, the presence of afluoropolymer coating or other anti-friction coating), propellant 235(e.g., an amount of the propellant, a mix of chemicals comprising thepropellant, a pressure profile of the ignited propellant 235 subsequentto ignition), payload 255 (a viscosity, density, degree of shearthickening, osmolarity, or other properties of a fluid of the payload255 controlled or affected by the addition of gelling agents or othersubstances; a geometry, size, and/or rigidity of a microelectronicdevice or of some other solid, gel, or semi-solid objects of the payload255; some other properties of the payload 255), or other elements of thedevice 200 could be specified to control an amount , a rate of delivery,a timing of delivery (e.g., a timing relative to driving the hollowneedle 120 into the skin 205 and/or relative to retraction of the hollowneedle 220 form the skin 205), a depth or delivery, or other propertiesof the delivery of the payload 255 into the skin 205, or to control someother properties of operation of the device 200.

FIG. 2D shows the piston 230 and hollow needle 220 retracted from theskin 205 partially due to venting of propellant gases through thechamber vent 232 (indicated by the arrow) and the force generated by thespring 237 due to compression of the spring 237 by the movement of thepiston 230 downward when driving the hollow needle 220 into the skin 205(shown in FIGS. 2B and 2C). FIG. 2D additionally shows a puncture 207formed in the skin 205 by the piston 230 driving the hollow needle 220into the skin 205. Properties of the spring 237, piston 230, hollowneedle 220, chamber 231, propellant 235, or other elements of the device200 could be specified to maximize the speed with which the needle 220is retracted from the skin 205 and/or minimize the duration during whichthe needle 220 pierces the skin 205 to, e.g., reduce discomfort inducedin a user by operation of the device to penetrate the skin 205.

FIG. 2E shows blood 209 emitted from the skin 205 (e.g., from thepuncture 207 formed in the skin 205). The sensor 240 is exposed to theblood 209. This could include suction generated by the device 200drawing the blood 209 form the puncture 207 to the sensor 240.Additionally or alternatively, the blood 209 could be directed to thesensor 240 by hydrophobic and/or hydrophilic coatings on one or moresurfaces of elements of the device 200 (e.g., of the housing 210). Forexample, a path from the puncture 207 to the sensor 240 could be coatedwith a hydrophilic substance; other surfaces of the device 200 thatcould come into contact with the blood 209 could be coated with ahydrophobic substance. Additionally or alternatively, elements of thedevice 200 (e.g., a capillary tube or channel formed, e.g., in thehousing 210) could be sized to direct the blood 209 using capillaryaction. Elements of the device 100 (e.g., the sensor 140, a bloodcollection element) could include a coating of heparin or some otherpharmaceutical to reduce coagulation and/or clotting of the blood 209 onor in the device (e.g., to increase the duration and/or amount of blood209 flowing into the device 200 and/or to the sensor 240).

Note that a device could include more components than those illustratedin FIGS. 1A, 1B, and 2A-E and/or could lack some elements and/orfeatures illustrated in FIGS. 1A, 1B, and 2A-E. For example, a devicecould lack the spring 137/237, could lack the vent 132/232, and/or couldbe otherwise configured not to automatically retract the hollow needle120/220 subsequent to driving the hollow needle 120/220 into skin.Further, a device could lack a suction source (e.g., 141) and/or sensor(e.g., 140/240) and/or include a blood collection element.

In some examples, a device could be configured to draw, receive, orotherwise collect blood emitted from skin pierced by the hollow needle120/220 through the needle channel 125. For example, the reservoir150/250 could include a spring, an elastic member, an elastic membrane,or some other mechanically resilient element configured to counter forceapplied to reduce a volume of the reservoir 150 by the propellant 135and/or by some other element of an injector or some other system of thedevice 100. Such a counter force could act to increase a volume of thereservoir to provide suction through the hollow needle such the blood orother fluids from the skin are drawn into the device through the hollowneedle.

Such a mechanically resilient element could be provided according toadditional or alternative applications, e.g., to control a timing orsome other property of the delivery of a payload into skin. As anexample, FIG. 3A shows a device 300 including a hollow needle 320coupled to a piston 330 disposed in a chamber 331 formed in the device300. The piston 330 includes a reservoir 350 containing a fluid payload(e.g., a drug, an inoculant). The reservoir 350 is coupled to the hollowneedle 320 and contains a mechanically resilient element (i.e., a spring337) configured to apply a force that is counter to a force applied bythe propellant 335 that is, in FIG. 3A, expanding to drive the hollowneedle 320 into skin by applying a force on the piston 330.

FIG. 3B shows the device 300 when the propellant 335 has exertedsufficient force to drive the hollow needle 320 into the skin. Further,the force exerted by the propellant (e.g., related to the increasingpressure of the propellant) is sufficient to overcome the force appliedby the spring 337 such that a volume of the reservoir 350 is reduced,delivering the fluid payload from the reservoir 350 into the skinthrough the hollow needle 320. Additionally or alternatively, such amechanically resilient element (e.g., a spring 337, an elastic membrane)could be provided to control a timing of delivery of the fluid payloadfrom the reservoir 350 through the hollow needle 320. For example, thespring 337 could be provided in the reservoir 550 to increase a forceapplied by the propellant 135 that is necessary to reduce the volume ofthe reservoir 150 such that the timing of delivery of the fluid payload155 is delayed.

A device could be configured in a variety of different ways to drive ahollow needle into skin and to deliver a payload into the skin throughthe hollow needle. In some examples, this could include accelerating thehollow needle and/or some other elements of the device (e.g., a piston,a reservoir containing the payload and coupled to the hollow needle)toward the skin and then arresting the motion of the hollow needle in amanner that results in the payload being delivered through the hollowneedle, e.g., by converting the motion of the hollow needle and/or otherelements of the device into a force applied to reduce a volume of thereservoir containing the payload. As an example, FIG. 4A shows a device400 including a hollow needle 420 coupled to a piston 430 disposed in achamber formed in the device 400. The piston 430 includes a reservoir450 containing a fluid payload (e.g., a drug, an inoculant). Thereservoir 450 is coupled to the hollow needle 420. The propellant 435is, in FIG. 4A, expanding to drive the hollow needle 420 into skin byapplying a force on the piston 430.

FIG. 4B shows the device 400 when the propellant 435 has exertedsufficient force to drive the hollow needle 420 into the skin. A stop417 formed in the device 400 has arrested the motion of the hollowneedle 420, piston 430, and reservoir 450; further, the stop 417arresting the hollow needle 420, piston 430, and reservoir 450 causesthe stop 417 to apply a force to reduce a volume of the reservoir 450such that fluid payload is delivered from the reservoir 450 into theskin through the hollow needle 420. Additionally or alternatively, forceapplied by the expanding propellant 435 could exert a force, through thestop 417, to reduce a volume of the reservoir 450 such that fluidpayload is delivered from the reservoir 450 into the skin through thehollow needle 420.

In another example, FIG. 5A shows a device 500 including a hollow needle520 coupled to a piston 530 disposed in a chamber formed in the device500. The piston 530 includes a reservoir 550 containing a fluid payload(e.g., a drug, an inoculant). The reservoir 550 is coupled to the hollowneedle 520. The reservoir includes a driving mass 557 configured toslidably move within the piston 530. The propellant 535 is, in FIG. 5A,expanding to drive the hollow needle 520 into skin by applying a forceon the piston 530 to accelerate the hollow needle 520, the piston 530,the reservoir 550, and the driving mass 557 toward the skin.

FIG. 5B shows the device 500 when the propellant 535 has exertedsufficient force to drive the hollow needle 520 into the skin. A stopformed in the device 500 has arrested the motion of the hollow needle520, piston 530, and reservoir 550 toward the skin. The driving mass 557has a sufficient mass to continue moving toward the skin subsequent tothe stop arresting the motion of the hollow needle 520, piston 530, andreservoir 550. The continued motion of the driving mass 557 causes thedriving mass 557 to apply a force to reduce a volume of the reservoir550 such that fluid payload is delivered from the reservoir 550 into theskin through the hollow needle 520.

A driving mass of a device (e.g., 557) that is configured to continuemoving subsequent to the arrest of the motion of a hollow needle (e.g.,520) and/or other elements (e.g., 530, 550) of a device by skin, by astop of the device, and/or by some other element(s) of the device couldbe coupled to a payload and/or to a reservoir containing such a payloadin a variety of ways to allow the continued motion of the driving massto deliver the payload into the skin through the hollow needle. As anexample, FIG. 6A shows a device 600 including a hollow needle 620coupled to a piston 630 disposed in a chamber formed in the device 600.The channel of the hollow needle 620 comprises a reservoir 650containing a fluid payload (e.g., a drug, an inoculant). A driving mass637 is disposed in the piston 630 and configured to slidably move withinthe piston 630. An inner needle 639 is disposed at least partiallywithin the channel of the hollow needle 620 and is coupled to thedriving mass 637. The propellant 635 is, in FIG. 6A, expanding to drivethe hollow needle 620 into skin by applying a force on the piston 630 toaccelerate the hollow needle 620, the piston 630, the inner needle 639,and the driving mass 637 toward the skin.

FIG. 6B shows the device 600 when the propellant 635 has exertedsufficient force to drive the hollow needle 620 into the skin. A stopformed in the device 600 has arrested the motion of the hollow needle620 and piston 630 toward the skin. The driving mass 637 and innerneedle 639 have a sufficient mass to continue moving toward the skinsubsequent to the stop arresting the motion of the hollow needle 620 andpiston 630. The continued motion of the driving mass 637 and innerneedle 639 causes the driving mass 637 and inner needle 639 to apply aforce to reduce a volume of the reservoir 650 such that the fluidpayload is delivered from the reservoir 650 into the skin.

In some examples, the injector could act to couple the channel of thehollow needle with a fluid-containing reservoir (e.g., a reservoircontaining a payload fluid under pressure) by opening a valve, movingthe needle and/or reservoir relative to each other such that they arecoupled, by breaching a seal, or by some other coupling means such thatthe payload is able to be delivered through the hollow needle subsequentto driving the hollow needle into the skin. In an example, FIG. 7A showsa device 700 including a hollow needle 720 coupled to a piston 730disposed in a chamber formed in the device 700. The hollow needle 720passes through two seals 737 and includes a side-channel 725 connectedto the channel in the hollow needle 720. The device 700 includes areservoir 750 containing a fluid payload (e.g., a drug, an inoculant).The reservoir 550 extends into the space between the two seals 737. Thepropellant 735 is, in FIG. 7A, expanding to drive the hollow needle 720into skin by applying a force on the piston 730 to drive the hollowneedle 720 into the skin.

FIG. 7B shows the device 700 when the propellant 735 has exertedsufficient force to drive the hollow needle 720 into the skin. Themotion of the hollow needle 720 in the chamber has caused the sidechannel 725 to enter the space between the seals 737. As a result, thereservoir 750 is coupled to the channel of the hollow needle 720,allowing the payload to be delivered into the skin through the channelof the hollow needle 720. In some examples, this could include thereservoir 750 being pressurized (i.e., the payload and/or other fluids(e.g., air pocket(s)) within the reservoir 750 could be at a higherpressure than the environment surrounding the device 700/in the skin).The reservoir could be pressurized during manufacture (e.g., the sealsand other elements of the device 700 could be configured to maintain ahigh pressure within the reservoir 750 from the time of manufacture ofthe device 700 until use). In some examples, the reservoir 750 could bepressurized prior to driving the hollow needle 720 into the skin using apump or by some other means. For example, a vent, membrane, or otherelements could be included to transmit some of the pressure produced bythe ignited propellant 735 into the reservoir 750 to pressurize thereservoir 750 .Note that the configurations and operations of devices asdescribed herein are meant as non-limiting examples of operation ofdevices configured to puncture skin, to deliver fluids and/or otherpayloads into the skin, and/or to receive blood emitted from the skin inresponse to being punctured. Such devices could include a variety ofmeans for penetrating or piercing skin, for driving such penetratingmeans into skin, for delivering such payloads into the skin, forsubsequently retracting such penetrating means from the skin, fordrawing, wicking, suctioning, or otherwise receiving blood responsivelyemitted from the skin, for storing the received blood, for sensing oneor more properties of the received blood, for moving, directing,preserving, or otherwise interacting with the received blood, or forperforming some additional or alternative operations of functionsaccording to an application.

III. Example Devices

Payload-delivering and/or blood-accessing devices as described hereincan be configured to be mounted to an external body surface of a wearerand to enable a variety of applications and functions including deliverof fluids, vaccines, inoculants, and/or other payloads into the body ofa person, accessing blood of the person (e.g., drawing, extracting, orotherwise receiving blood), storing such accessed blood, detecting oneor more properties of such accessed blood, detecting some otherproperties of the body of the person (e.g., a pulse rate), or performingsome other functions. Such devices could enable a variety ofapplications, including measuring homological properties or otherphysiological information about a person, indicating such measuredinformation or other information to the person (e.g., using a vibrator,a screen, a beeper), recording such information, indicating suchinformation to a remote system (e.g., a server in a physician's office),or other functions.

In some examples, a payload-delivering and/or blood-accessing device isprovided as a handheld device, as shown in FIGS. 8A and 8B. The handhelddevice 800 may be mounted to the skin of a living subject by positioningthe device 800 (e.g., by positioning a contact surface 815 of the device800) proximate the skin. The handheld device 800 can be configured todeliver a payload into skin of a living subject, to access blood of aliving subject, and to store, detect a property of, or otherwiseinteract with such accessed blood. In order to deliver payloads toand/or access blood from within and/or beneath skin of the livingsubject, the handheld device may be positioned on a portion of the bodywhere subsurface vasculature or other targets or elements of the livingsubject are easily accessed (e.g., punctured), the qualification ofwhich will depend on the type of system used. A housing 810 is providedto permit manual positioning of the device 800 on the living subject. Acontact surface 815 of the device 800 is intended to be mounted facingto the external body surface. The device 800 may include sensors (e.g.,830) disposed on the contact surface 815 and/or within the housing 810for detecting one or more physiological properties of the wearer (e.g.,a pulse, a blood oxygenation, a galvanic skin response). The contactsurface 815 additionally includes a concave depression 820. The concavedepression 820 corresponds to a payload delivering and/orblood-accessing section of the device 800 that can be operated to drivea hollow needle, through the concave depression (e.g., through a seal ofthe device and/or through a channel of the device configured to allowthe passage of the hollow needle), into skin of a wearer and to delivera payload into the skin of the wearer through the hollow needle. Thedevice 800 could additionally be operated to subsequently retract thehollow needle from the skin. Further, the payload delivering and/orblood-accessing section could be configured to receive bloodresponsively emitted from the skin (e.g., by wicking, capillary action,application of suction, or some other means) and to store, detect aproperty of, or otherwise interact with the received blood (e.g., todetect a property of emitted blood that comes into contact with thesensor 830).

The handheld device 800 may also include a display 850 where a visualindication of information about the operation of the device 800 may bedisplayed. The display 850 may further be configured to provide anindication of a measured hemodynamic property of blood accessed from thebody of the wearer using the device (e.g., to provide an indication of ablood glucose level of the wearer's blood). Further, the handheld device800 may include one or more buttons 840 for accepting inputs from thewearer. For example, the button 840 may be configured to accept inputsfor controlling aspects of the device 800, such as initiating ameasurement period (e.g., causing the device 800 to access blood of thewearer by driving a needle into skin or according to some other method),and/or initiating a delivery of a payload (e.g., a fluid containinginsulin) into skin of the wearer.

In some examples, a wearable device is provided as a wrist-mounteddevice, as shown in FIGS. 9A and 9B. The wrist-mounted device 900 may bemounted to the wrist of a living subject with a wristband or cuff,similar to a watch or bracelet. The wearable device 900 can beconfigured to deliver a payload into skin of a wearer, to access bloodof a wearer, and to store, detect a property of, or otherwise interactwith such accessed blood. The term “wearable device,” as used in thisdisclosure, refers to any device that is capable of being worn at, on orin proximity to a body surface, such as a wrist, ankle, waist, chest, orother body part. In order to deliver payloads into and/or access bloodfrom within and/or beneath skin of the body, the wearable device may bepositioned on a portion of the body where subsurface vasculature orother targets or elements of the body of the wearer are easily accessed(e.g., punctured), the qualification of which will depend on the type ofsystem used. A mount 910, such as a belt, wristband, ankle band, etc.can be provided to mount the device at, on or in proximity to the bodysurface. The mount 910 may prevent the wearable device from movingrelative to the body to allow for blood to be drawn from a punctureproduced in the skin by the device 900 (e.g., by a driven andsubsequently retracted needle of the device) or according to some otherapplication or consideration. In one example, shown in FIGS. 9A and 9B,the mount 910 may take the form of a strap or band 920 that can be wornaround the wrist (or some other part) of the body. Further, the mount910 may be an adhesive substrate for adhering the payload deliveringand/or blood-accessing device 900 to the body of a wearer.

A housing 930 is disposed on the mount 910 such that it can bepositioned on the body. A contact surface 940 of the housing 930 isintended to be mounted facing to the external body surface. The housing930 may include sensors for detecting one or more physiologicalproperties of the wearer (e.g., a pulse, a blood oxygenation, a galvanicskin response). The contact surface 940 additionally includes a numberof concave depressions 950. Each concave depression 950 corresponds to apayload delivering and/or blood-accessing section of the device 900 thatcan be operated to drive a hollow needle, through the concave depression(e.g., through a seal of the device and/or through a channel of thedevice configured to allow the passage of the needle), into skin of awearer, to deliver a payload into the skin of the wearer through thehollow needle, and subsequently to retract the needle from the skin.Further, each section is configured to receive blood responsivelyemitted from the skin (e.g., by wicking, capillary action, applicationof suction, or some other means) and to store, detect a property of, orotherwise interact with the received blood.

The housing 930 could be configured to be water-resistant and/orwater-proof. That is, the housing 930 could be configured to includesealants, adhesives, gaskets, welds, transparent windows, apertures,press-fitted seams, and/or other joints such that the housing 930 isresistant to water entering an internal volume or volumes of the housing930 when the housing 930 is exposed to water. The housing 930 couldfurther be water-proof, i.e., resistant to water entering an internalvolume or volumes of the housing 930 when the housing 930 is submergedin water. For example, the housing 930 could be water-proof to a depthof 1 meter, i.e., configured to resist water entering an internal volumeor volumes of the housing 930 when the housing 930 is submerged to adepth of 1 meter.

The wearable device 900 may also include a user interface 990 via whichthe wearer of the device may receive one or more recommendations oralerts generated either from a remote server or other remote computingdevice, or from a processor within the device. The alerts could be anyindication that can be noticed by the person wearing the wearable device900. For example, the alert could include a visual component (e.g.,textual or graphical information on a display), an auditory component(e.g., an alarm sound), and/or tactile component (e.g., a vibration).Further, the user interface 990 may include a display 992 where a visualindication of the alert or recommendation may be displayed. The display992 may further be configured to provide an indication of a measuredhemodynamic property of blood accessed from the body of the wearer usingthe device (e.g., to provide an indication of a blood glucose level ofthe wearer's blood).

Further, the user interface 990 may include one or more buttons 994 foraccepting inputs from the wearer. For example, the buttons 994 may beconfigured to change the text or other information visible on thedisplay 992. The buttons 994 may be configured to accept inputs forcontrolling aspects of the data collection system, such as initiating ameasurement period (e.g., causing the device 900 to access blood of thewearer by driving a needle into skin or according to some other method),initiating a delivery of a payload (e.g., a fluid containing insulin)into skin of the wearer, inputs indicating the wearer's current healthstate (i.e., normal, migraine, shortness of breath, heart attack, fever,“flu-like” symptoms, food poisoning, etc.), or inputs indicating thewearer's activities (e.g., eating a meal, taking a medication).

Note that example devices herein are configured to be mounted to a wristof a wearer. However, the embodiments described herein could be appliedto other body parts (e.g., an ankle, a thigh, a chest, an abdomen, aforehead, a thigh, a finger), or to detect hematological properties orother physiological properties in other environments. For example,embodiments described herein could be applied to detect one or moreproperties in a target environment (e.g., a natural environment, anenvironment of an industrial, pharmaceutical, or water treatmentprocess).

Payload-delivering and/or blood-accessing sections of example devices900, 800 could be single-use; for example, an injector of one or moresections could ignite a limited supply of a propellant and/or whereinsuction is provided for/in a section by a single evacuated volume. Insuch examples, such single and/or limited-use payload delivering and/orblood-accessing sections could be configured to be a removable and/orreplaceable element of the device 900/800. Wearable 900 and/or handheld800 devices could be configured to operate single and/or limited-usepayload delivering and/or blood-accessing sections of such a removableand/or replaceable element to access a number of samples of blood fromskin (e.g., at respective specified points in time) and/or to deliver anumber of different payload and/or amounts of a fluid or otherwisenon-discrete payload. Once the body-mountable 900, handheld 800, orotherwise configured device has operated all of the sections of theremovable and/or replaceable element, the removable and/or replaceableelement could be removed from the body-mountable 900, handheld 800, orotherwise configured device and replaced. In some examples, this couldinclude operating one or more injectors, suction sources, and/or othercomponents of the removable and/or replaceable element (e.g., via anelectrical connector, an optical receiver/transmitter, and/orelectronics). Additionally or alternatively, the body-mountable 900,handheld 800, or otherwise configured device could operate the removableand/or replaceable element using other means, e.g., by ignitingpropellant of the removable and/or replaceable element by heating thepropellant using a laser of the body-mountable 900, handheld 800, orotherwise configured device.

In some examples, the removed removable and/or replaceable element couldbe configured to store blood, and blood stored in the removed removableand/or replaceable element could be presented to a sensing device foranalysis (e.g., the removed removable and/or replaceable element couldbe sent via post to a sensing device at a laboratory that is remote froma user of the body-mountable 900, handheld 800, or otherwise configureddevice). For example, samples of blood stored within the removableand/or replaceable element could be accessed via ports of the removableand/or replaceable element.

Payload-delivering and/or blood-accessing devices and other embodimentsas described herein can include a variety of components configured in avariety of ways. Devices described herein could include electronicsincluding a variety of different components configured in a variety ofways to enable applications of the wearable device. The electronicscould include controllers, amplifiers, switches, display drivers, touchsensors, wireless communications chipsets (e.g., Bluetooth radios orother radio transceivers and associated baseband circuitry to enablewireless communications between the wearable device and some othersystem(s)), or other components. The electronics could include acontroller configured to operate one or more sensors, injectors,reservoirs, suction sources, and/or components of a payload-deliveringand/or blood-accessing device to deliver a fluid, object, or otherpayload into the body, to detect one or more hematological or otherproperties of a body, and/or to access and store or otherwise interactwith blood from within and/or beneath skin of the body. The controllercould include a processor configured to execute computer-readableinstructions (e.g., program instructions stored in data storage of thewearable device) to enable applications of the device. The electronicscan include additional or alternative components according to anapplication of the device.

Wearable or otherwise-configured payload-delivering and/orblood-accessing devices as described herein could include one or moreuser interfaces. A user interface could include a display configured topresent an image to a user and to detect one or more finger presses of auser on the interface. The controller or some other component(s) of theelectronics could operate the user interface to provide information to awearer or other user of the device and to enable the wearer or otheruser to affect the operation of the device, to determine some propertyof the device and/or of the user of the device (e.g., a hematologicalproperty of blood and/or a health state of a user of the device), or toprovide some other functionality or application to the wearer and/oruser. As one example, the user could press an indicated region of theuser interface to indicate that the device should begin logging detectedmedical information about the user. Other indicated information, changesin operation of the device, or other functions and applications of theuser interface are anticipated.

Note that the embodiments illustrated in the Figures are illustrativeexamples and not meant to be limiting. Alternative embodiments,including more or fewer components in alternative configurations areanticipated. A wearable, handheld, body-mountable, desktop, or otherwiseconfigured device could include multiple housings or other suchassemblies each containing some set of components to enable applicationsof such a device. A payload-delivering and/or blood-accessing device asdescribed herein could be configured to perform a variety of functionsand to enable a variety of applications. Payload-delivering and/orblood-accessing devices could be configured to operate in concert withother devices or systems; for example, payload-delivering and/orblood-accessing devices could include a wireless communication interfaceconfigured to transmit data indicative of one or more properties of theblood of a wearer of the wearable device. Other embodiments, operations,configurations, and applications of a blood-accessing device asdescribed herein are anticipated.

FIG. 10 is a simplified schematic of a system including one or morewearable payload-delivering and/or blood-accessing devices 1000. The oneor more wearable devices 1000 may be configured to transmit data via acommunication interface 1010 over one or more communication networks1020 to a remote server 1030. In one embodiment, the communicationinterface 1010 includes a wireless transceiver for sending and receivingcommunications to and from the server 1030. In further embodiments, thecommunication interface 1010 may include any means for the transfer ofdata, including both wired and wireless communications. For example, thecommunication interface may include a universal serial bus (USB)interface or a secure digital (SD) card interface. Communicationnetworks 1020 may be any one of may be one of: a plain old telephoneservice (POTS) network, a cellular network, a fiber network and a datanetwork. The server 1030 may include any type of remote computing deviceor remote cloud computing network. Further, communication network 1020may include one or more intermediaries, including, for example whereinthe wearable device 1000 transmits data to a mobile phone or otherpersonal computing device, which in turn transmits the data to theserver 1030.

In some examples, multiple wearable devices 1000 could be configured todeliver fluid or other payloads into skin of, to access blood fromand/or detect multiple hematological or other properties of a singlewearer. For example, the single wearer could wear or otherwise operatetwo or more wearable devices 1000 to measure respective hematological orother physiological properties from respective two or more portions ofthe body of the wearer (e.g., respective portions of subsurfacevasculature of the wearer) and/or during different periods of time(e.g., the wearable devices 1000 used by the wearer could be limited-usedevices, e.g., each including a discrete number of single-useblood-accessing sections).

In addition to receiving communications from the wearable device 1000,such as collected hematological properties or other collectedphysiological properties and data regarding health state as input by theuser and/or one or more properties of a wearer detected using a sensordisposed in the wearable device 1000, the server may also be configuredto gather and/or receive either from the wearable device 1000 or fromsome other source, information regarding a wearer's overall medicalhistory, environmental factors and geographical data. For example, auser account may be established on the server for every wearer thatcontains the wearer's medical history. Moreover, in some examples, theserver 1030 may be configured to regularly receive information fromsources of environmental data, such as viral illness or food poisoningoutbreak data from the Centers for Disease Control (CDC) and weather,pollution and allergen data from the National Weather Service. Further,the server may be configured to receive data regarding a wearer's healthstate from a hospital or physician. Such information may be used in theserver's decision-making process, such as recognizing correlations andin generating clinical protocols.

Additionally, the server may be configured to gather and/or receive thedate, time of day and geographical location of each wearer of the deviceduring each measurement period. Such information may be used to detectand monitor spatial and temporal spreading of diseases. As such, thewearable device may be configured to determine and/or provide anindication of its own location. For example, a wearable device mayinclude a GPS system so that it can include GPS location information(e.g., GPS coordinates) in a communication to the server. As anotherexample, a wearable device may use a technique that involvestriangulation (e.g., between base stations in a cellular network) todetermine its location. Other location-determination techniques are alsopossible.

The server may also be configured to make determinations regarding theefficacy of a drug or other treatment based on information regarding thedrugs or other treatments received by a wearer of the device and, atleast in part, the hematological property data and the indicated healthstate of the user. From this information, the server may be configuredto derive an indication of the effectiveness of the drug or treatment.For example, if a drug is intended to control a blood sugar of a wearerand the wearer of the device does not indicate that they areexperiencing nausea, lightheadedness, or other sequelae after beginninga course of treatment with the drug, the server may be configured toderive an indication that the drug is effective for that wearer.

Further, some embodiments of the system may include privacy controlswhich may be automatically implemented or controlled by the wearer ofthe device. For example, where a wearer's collected hematologicalproperty data and health state data are uploaded to a cloud computingnetwork for trend analysis by a clinician, the data may be treated inone or more ways before it is stored or used, so that personallyidentifiable information is removed. For example, a user's identity maybe treated so that no personally identifiable information can bedetermined for the user, or a user's geographic location may begeneralized where location information is obtained (such as to a city,ZIP code, or state level), so that a particular location of a usercannot be determined.

Additionally or alternatively, wearers of a device may be provided withan opportunity to control whether or how the device collects informationabout the wearer (e.g., information about a user's medical history,social actions or activities, profession, a user's preferences, or auser's current location), or to control how such information may beused. Thus, the wearer may have control over how information iscollected about him or her and used by a clinician or physician or otheruser of the data. For example, a wearer may elect that data, such ashealth state and hematological properties, collected from his or herdevice may only be used for generating an individual baseline andrecommendations in response to collection and comparison of his or herown data and may not be used in generating a population baseline or foruse in population correlation studies.

IV. Example Electronics

FIG. 11 is a simplified block diagram illustrating the components of adevice 1100, according to an example embodiment. Device 1100 may takethe form of or be similar to one of the payload-delivering and/orblood-accessing devices 100, 200, 300, 400, 500, 600, 700, 900, 1000shown in FIGS. 1A-B, 2A-E, 3A-B, 4A-B, 5A-B, 6A-B, 7A-B, 9A-B, and 10.However, device 1100 may also take other forms, such as an ankle, waist,or chest-mounted device. Device 1100 could also take the form of adevice that is not configured to be mounted to a body. For example,device 1100 could take the form of a handheld device configured to bemaintained in proximity to skin by a user or operator of the device 1000or by a frame or other supporting structure, e.g., device 800. Device1100 also could take other forms.

In particular, FIG. 11 shows an example of a device 1100 having first1110 and second 1120 payload-delivering and/or blood-accessing sections,a user interface 1130, communication interface 1135 for transmittingdata to a remote system, and a controller 1140. The components of thedevice 1100 may be disposed on a mount or on some other structure formounting the device to enable stable collection of blood emitted fromskin in response to penetration of the skin by one or more needles ofthe device 1100, for example, mounting to an external body surface whereone or more portions of subsurface vasculature or other anatomicalelements are readily accessible.

Controller 1140 may be provided as a computing device that includes oneor more processors 1150. The one or more processors 1150 can beconfigured to execute computer-readable program instructions 1170 thatare stored in the computer readable data storage 1160 and that areexecutable to provide the functionality of a device 1100 describedherein.

The computer readable medium 1160 may include or take the form of one ormore non-transitory, computer-readable storage media that can be read oraccessed by at least one processor 1150. The one or morecomputer-readable storage media can include volatile and/or non-volatilestorage components, such as optical, magnetic, organic or other memoryor disc storage, which can be integrated in whole or in part with atleast one of the one or more processors 1150. In some embodiments, thecomputer readable medium 1160 can be implemented using a single physicaldevice (e.g., one optical, magnetic, organic or other memory or discstorage unit), while in other embodiments, the computer readable medium1160 can be implemented using two or more physical devices.

First 1110 and second 1120 payload-delivering and/or blood-accessingsections could include any components configured to drive a needle intoskin, to deliver a payload (e.g., a drug-containing fluid) into theskin, to subsequently retract the needle from the skin, to receive bloodfrom the resulting puncture in the skin (e.g., by applying suction tothe skin), and/or to perform other functions as described elsewhereherein. Payload-delivering and/or blood-accessing sections could includemotors, piezoelectric transducers, solenoids, actuated valves, resistiveheaters or other propellant-igniting components, or other components ofan injector configured to drive a hollow needle into skin, to deliver apayload through the hollow needle into the skin, and/or to subsequentlyretract such a needle. Payload-delivering and/or blood-accessingsections 1110, 1120 could include blood-storage elements as describedelsewhere herein to store blood for, e.g., later analysis.Payload-delivering and/or blood-accessing sections 1110, 1120 couldinclude sensors configured to detect a variety of properties of blooddrawn, wicked, suctioned, received, or otherwise accessed by theblood-accessing sections 1110, 1120. Payload- delivering and/orblood-accessing sections 1110, 1120 could include pumps or otherelements (e.g., evacuated volumes) configured to provide suction (e.g.,to draw skin toward and/or into concave depressions of theblood-accessing sections 1110, 1120, to draw blood from the skin intothe device 1100, to direct blood within the device, 1100, e.g., to oneor more sensors, blood-storage elements, or other components of thedevice 1100). The device 1100 could include additional (or fewer)payload-delivering and/or blood-accessing sections. Thepayload-delivering and/or blood-accessing sections 1110, 1120 could besimilarly or differently configured. The payload-delivering and/orblood-accessing sections 1110, 1120 could be part of a removable and/orreplaceable portion of the device 1100. The device 1100 may includefurther sensors (not shown), e.g., heart rate sensors, galvanic skinresponse sensors, pulse oximeters, or other sensors configured to detectone or more properties of the body of a user and/or of the environmentof the device 1100.

The program instructions 1170 stored on the computer readable medium1160 may include instructions to perform any of the methods describedherein. For instance, in the illustrated embodiment, programinstructions 1170 include a controller module 1172, calculation anddecision module 1174 and an alert module 1176.

Calculation and decision module 1174 may include instructions foroperating the payload-delivering and/or blood-accessing sections 1110,1120 and analyzing data generated by the payload-delivering and/orblood-accessing sections 1110, 1120 (e.g., by sensors thereof) todetermine one or more hematological properties of blood or otherinformation (e.g., health states) of a body of a user of the device1100, such as a blood glucose level at a number of points in time.Calculation and decision module 1174 can additionally includeinstructions for analyzing the data to determine if a medical conditionor other specified condition is indicated, or other analytical processesrelating to the environment proximate to the device 1100 (e.g., based oninformation generated by additional sensors of the device 1100). Inparticular, the calculation and decision module 1174 may includeinstructions for operating the first 1110 and second 1120payload-delivering and/or blood-accessing sections to deliver a payload(e.g., a fluid containing a drug) at a specified point or points intime, to deliver a specified amount of the payload, to deliver aspecified payload of a discrete set of possible payloads (e.g., a set offluids containing different drugs), or according to some otherapplication. The calculation and decision module 1174 may additionallyinclude instructions for operating the first 1110 and second 1120payload-delivering and/or blood-accessing sections to access blood(e.g., for operating resistive heating elements of thepayload-delivering and/or blood-accessing sections 1110, 1120 to ignitepropellant and drive respective needles into skin) at respectivespecified points in time (e.g., points in time while a wearer sleeps,points in time during the week).

The controller module 1172 can also include instructions for operating auser interface 1130. For example, controller module 1172 may includeinstructions for displaying data collected by the payload-deliveringand/or blood-accessing sections 1110, 1120 and analyzed by thecalculation and decision module 1174, or for displaying one or morealerts generated by the alert module 1176. Controller module 1172 mayinclude instructions for displaying data related to a detectedhematological property of accessed blood and/or a determined healthstate of a user. Further, controller module 1172 may includeinstructions to execute certain functions based on inputs accepted bythe user interface 1130, such as inputs accepted by one or more buttonsdisposed on the user interface (e.g., to operate one or both of thepayload-delivering and/or blood-accessing sections 1110, 1120 to delivera payload into skin, to access blood from a user and/or to detect one ormore properties of the accessed blood in response to an input from theuser).

Communication platform 1135 may also be operated by instructions withinthe controller module 1172, such as instructions for sending and/orreceiving information via a wireless antenna, which may be disposed onor in the device 1100. The communication interface 1135 can optionallyinclude one or more oscillators, mixers, frequency injectors, etc. tomodulate and/or demodulate information on a carrier frequency to betransmitted and/or received by the antenna. In some examples, the device1100 is configured to indicate an output from the processor bymodulating an impedance of the antenna in a manner that is perceivableby a remote server or other remote computing device.

The program instructions of the calculation and decision module 1174may, in some examples, be stored in a computer-readable medium andexecuted by a processor located external to the device 1100. Forexample, the device 1100 could be configured to collect certain dataregarding hematological properties from the user and then transmit thedata to a remote server, which may include a mobile device, a personalcomputer, the cloud, or any other remote system, for further processing.

The computer readable medium 1160 may further contain other data orinformation, such as medical and health history of a user of the device1100, a drug treatment regimen determined for a user of the device 1100,that may be useful in operating the device 1100 and/or determiningwhether a medical condition or some other specified condition isindicated. Further, the computer readable medium 1160 may contain datacorresponding to certain physiological parameter baselines, above orbelow which a medical condition is indicated. The baselines may bepre-stored on the computer readable medium 1160, may be transmitted froma remote source, such as a remote server, or may be generated by thecalculation and decision module 1174 itself. The calculation anddecision module 1174 may include instructions for generating individualbaselines for the user of the device 1100 based on data collected basedon a certain number of blood samples accessed using blood-accessingelements (e.g., 1110, 1120) of the device 1100. Baselines may also begenerated by a remote server and transmitted to the device 1100 viacommunication interface 1130. The calculation and decision module 1174may also, upon determining that a medical or other emergency conditionis indicated, generate one or more recommendations for the user of thedevice 1100 based, at least in part, on consultation of a clinicalprotocol. Such recommendations may alternatively be generated by theremote server and transmitted to the device 1100.

In some examples, the collected hematological property data, baselineprofiles, health state information input by device users and generatedrecommendations and clinical protocols may additionally be input to acloud network and be made available for download by a user's physician.Trend and other analyses may also be performed on the collected data,such as hemodynamic property data and health state information, in thecloud computing network and be made available for download by physiciansor clinicians.

Further, hematological property and health state data from individualsor populations of device users may be used by physicians or cliniciansin monitoring efficacy of a drug or other treatment. For example,high-density, real-time data may be collected from a population ofdevice users who are participating in a clinical study to assess thesafety and efficacy of a developmental drug or therapy. Such data mayalso be used on an individual level to assess a particular user'sresponse to a drug or therapy. Based on this data, a physician orclinician may be able to tailor a drug treatment to suit an individual'sneeds.

In response to a determination by the calculation and decision module1174 that a medical or other specified condition is indicated (e.g.,that a user is hyperglycemic or hypoglycemic, based on a detectedglucose level of blood accessed from the body of the user), the alertmodule 1176 may generate an alert via the user interface 1130. The alertmay include a visual component, such as textual or graphical informationdisplayed on a display, an auditory component (e.g., an alarm sound),and/or tactile component (e.g., a vibration). The textual informationmay include one or more recommendations, such as a recommendation thatthe user of the device contact a medical professional, operate one orboth of the payload-delivering elements 1110, 1120 to deliver a dose ofa pharmaceutical (e.g., insulin), seek immediate medical attention, oradminister a medication.

V. Example Methods

FIG. 12 is a flowchart of a method 1200 for operating apayload-delivering and/or blood-accessing system. The operated systemincludes: (i) a hollow needle that includes a channel and that isconfigured to penetrate skin, (ii) a reservoir that contains a fluid, agel, one or more solid or semi-solid objects, or some other payload,(iii) an injector, and (iv) a controller. The method 1200 includesmounting the system to skin (1210). The system could be a wearabledevice and mounting the system to skin (1210) could include mounting thesystem to and/or around a part of a body using a strap, adhesive, orsome other means. The system could be a handheld device and mounting thesystem to skin (1210) could include manually or otherwise positioningthe system proximate skin. The system could be a desktop device, a wall-or ceiling-mounted device, or some other form of stationary device andmounting the system to skin (1210) could include positioning a body parthaving the skin (e.g., a wrist, and arm) proximate the system.

The method 1200 also includes operating the injector to drive the hollowneedle into the skin to form a puncture and delivering a payload fromthe reservoir into skin through the channel of the hollow needle (1220).This could include the controller operating the injector at a specifiedpoint in time and/or in response to a command (e.g., a command receivedthrough a user interface of the system, a command generated by thesystem in response to detecting that skin is present proximate thesystem, a command generated by a remote system in communication with thepayload-delivering and/or blood-accessing system). Operating theinjector (1220) could additionally include drawing blood from the formedpuncture in the skin into the system using suction provided by a suctionsource. Operating the injector (1220) could include igniting apropellant, e.g., by heating the propellant using a resistive heatingelement. Additionally or alternatively, operating the injector (1220)could include operating a motor, solenoid, piezoelectric transducer, orother elements of the system and/or of the injector.

The system could include one or more sensors configured to detect one ormore properties of blood accessed by and drawn into the system and themethod 1200 could include operating the sensor to detect the one or moreproperties of the blood (e.g., to detect a glucose concentration in theblood). Additionally or alternatively, the system could include one ormore blood storage elements configured to receive and store bloodaccessed by the system and the method 1200 could include storing theaccessed blood. The method 1200 could further include providing bloodstored by the blood storage element to a sensing device and operatingthe sensing device to detect a property of the blood provided to thesensing device. In some examples, one or more elements, sections, orportions of the system (e.g., a section configured to drive a needleinto skin, to deliver a payload through the hollow needle into the skin,to subsequently retract the needle, and/or to apply suction to the skinto draw blood into the section) could be removable, and the method 1200could include removing and replacing such elements, sections, orportions subsequent to operating such elements, sections, or portions toaccess blood from skin.

The method 1200 could include additional or alternative steps. Themethod 1200 could include heating, applying suction to, or otherwisepreparing a portion of skin to emit blood in response to being piercedby a needle of the system. In some examples, the method 1200 couldinclude transmitting (e.g., wirelessly transmitting, transmitting via aBluetooth wireless link, transmitting via a cable, transmitting via theinternet or some other network) information indicative of a detectedhematological property of blood accessed by the system. In someexamples, the method 1200 could include determining a health state ofthe user based on a hematological property detected from blood accessedby the system. In some examples, the method 1200 could includeindicating a detected hematological properties or other informationabout the operation of the system to a user via a user interface of thesystem and/or indicating such information to a remote system (e.g., to aphysician's computer, via a wireless or other communications link).

The example method 1200 illustrated in FIG. 12 is meant as anillustrative, non-limiting example. Additional or alternative elementsof the method and additional or alternative components of the system areanticipated, as will be obvious to one skilled in the art.

VI. Conclusion

Where example embodiments involve information related to a person or adevice of a person, the embodiments should be understood to includeprivacy controls. Such privacy controls include, at least, anonymizationof device identifiers, transparency and user controls, includingfunctionality that would enable users to modify or delete informationrelating to the user's use of a product.

Further, in situations in where embodiments discussed herein collectpersonal information about users, or may make use of personalinformation, the users may be provided with an opportunity to controlwhether programs or features collect user information (e.g., informationabout a user's medical history, social network, social actions oractivities, profession, a user's preferences, or a user's currentlocation), or to control whether and/or how to receive content from thecontent server that may be more relevant to the user. In addition,certain data may be treated in one or more ways before it is stored orused, so that personally identifiable information is removed. Forexample, a user's identity may be treated so that no personallyidentifiable information can be determined for the user, or a user'sgeographic location may be generalized where location information isobtained (such as to a city, ZIP code, or state level), so that aparticular location of a user cannot be determined. Thus, the user mayhave control over how information is collected about the user and usedby a content server.

The particular arrangements shown in the Figures should not be viewed aslimiting. It should be understood that other embodiments may includemore or less of each element shown in a given Figure. Further, some ofthe illustrated elements may be combined or omitted. Yet further, anexemplary embodiment may include elements that are not illustrated inthe Figures.

Additionally, while various aspects and embodiments have been disclosedherein, other aspects and embodiments will be apparent to those skilledin the art. The various aspects and embodiments disclosed herein are forpurposes of illustration and are not intended to be limiting, with thetrue scope and spirit being indicated by the following claims. Otherembodiments may be utilized, and other changes may be made, withoutdeparting from the spirit or scope of the subject matter presentedherein. It will be readily understood that the aspects of the presentdisclosure, as generally described herein, and illustrated in thefigures, can be arranged, substituted, combined, separated, and designedin a wide variety of different configurations, all of which arecontemplated herein.

1-24. (canceled)
 25. A system comprising: a hollow needle, wherein thehollow needle comprises a channel, and wherein the hollow needlecomprises a first end that is configured to penetrate skin; a reservoir,wherein the reservoir contains a payload; an injector, wherein theinjector is configured to drive the hollow needle into the skin to forma puncture in the skin, wherein the injector is further configured todeliver the payload from the reservoir into the skin via the channel andto retract the hollow needle from the skin subsequent to driving thehollow needle into the skin; a suction source configured to providesuction, wherein the suction provided by the suction source isconfigured to draw blood from the puncture formed in the skin into thesystem, wherein the injector comprises: a chamber, wherein the hollowneedle is disposed at least partially within the chamber; and a pistondisposed in the chamber, wherein the hollow needle is coupled to thepiston, wherein the piston comprises the reservoir, and wherein thepiston is configured to slidably move within the chamber.
 26. The systemof claim 25, wherein the injector further comprises a propellant,wherein the propellant is configured to slidably move the piston withinthe chamber to drive the hollow needle into skin.
 27. The system ofclaim 25, wherein the system comprises a concave depression, wherein theinjector is configured to drive the hollow needle into skin proximatethe concave depression, and wherein the suction provided by the suctionsource is configured to suction the skin into the concave depression.28. The system of claim 25, further comprising a seal, wherein the sealis configured to receive suction provided by the suction source, whereinthe injector driving the hollow needle into the skin comprises drivingthe hollow needle through the seal to form at least one hole in theseal, and wherein the suction provided by the suction source isconfigured to draw blood from the puncture formed in the skin throughthe at least one hole formed in the seal into the system.
 29. The systemof claim 25, further comprising a blood storage element, wherein thesuction provided by the suction source is configured to draw blood intothe system to the blood storage element, and wherein the blood storageelement is configured to store blood drawn by the suction to the bloodstorage element.
 30. The system of claim 25, further comprising asensor, wherein the sensor is configured to detect a property of bloodto which the sensor is exposed, wherein the suction provided by thesuction source is configured to draw blood into the system to thesensor.
 31. The system of claim 25, wherein the payload contained by thereservoir comprises heparin.
 32. The system of claim 25, wherein thepropellant comprises nitrocellulose that is ignitable by the injector todrive the hollow needle into skin.
 33. The system of claim 25, furthercomprising: a controller, wherein the controller is configured toperform controller functions including operating the injector to drivethe hollow needle into the skin and to deliver the payload into the skinvia the channel.
 34. The system of claim 33, wherein the payloadcomprises an electronic biosensor, wherein the electronic biosensor isconfigured to be injected into the skin by the injector, and wherein theelectronic biosensor is configured to detect a property of the skin whenthe electronic biosensor is located in the skin.
 35. The system of claim33, wherein the payload comprises a plurality of analyte-sensitiveparticles, wherein the analyte-sensitive particles are configured toselectively interact with an analyte in the skin, and wherein theanalyte-sensitive particles are configured to emit electromagneticenergy related to a property of the analyte in the skin in response toreceiving interrogating electromagnetic energy.
 36. The system of claim33, wherein the payload comprises a fluid containing gelling agents. 37.The system of claim 33, further comprising: a driving mass, wherein theinjector driving the hollow needle into the skin to form a puncture inthe skin comprises accelerating the hollow needle, the driving mass, andthe reservoir toward the skin; and a stop configured to arrest themotion of the hollow needle and the reservoir toward the skin, whereinthe driving mass is configured to continue moving subsequent to the stoparresting motion of the reservoir such that the driving mass applies aforce to reduce a volume of the reservoir.
 38. The system of claim 33,wherein the injector is configured to deliver the payload from thereservoir into the skin by applying a force to reduce a volume of thereservoir.
 39. The system of claim 38, wherein the reservoir comprises amechanically resilient element, wherein the mechanically resilientelement is configured to apply a force that is counter to the forceapplied by the injector to reduce the volume of the reservoir.
 40. Thesystem of claim 33, wherein the controller is configured to operate theinjector at a specified point in time.
 41. The system of claim 33,wherein the controller is configured to operate the injector in responseto a command and/or behavior detected by a sensor.